Emergency Use can be a confusing exception within the regulations.

Sometimes patients have a life-threatening or possibly severely debillitating condition where there are no acceptable treatment alternatives. In such a case a clinician may use an unapproved treatment/article (drug, device or other) prior to obtaining IRB approval. The clinician however must submit the IRB's Emergency Use paperwork within 5 days of the using the unapproved article.

Usually the manufacturer of the unapproved article requires the clinician to obtain an acknowledgement from the IRB chair that this meets Emergency Use conditions. You may contact our chairs directly to obtain such an acknowledgement. Our Chairman, Dr. Iafrate, can be reached at 352-773-0434.

It is important to note: Emergency Use is not identical to Compassionate Use or Treatment INDs. The usual difference between Emergency Use and these categories is that in Compassionate Use/Treatment INDs: (a) the patient doesn't have a life-threatening/severely debillitating condition, and/or (b) there are alternative treatments available. Compassionate Use and Treatment INDs require regular Full Board approval prior to their use. You must submit all of the paperwork required for Full Board protocols (Introductory Questionnaire, Protocol, Informed Consent form, etc).

NOTE: the regulations indicate that each institution may only use an article Emergently once. Regulations indicate that researchers at the institution must obtain IRB approval prior to any subsequent uses of the article. What happens if another patient arrives and needs the test article emergently? If you or another investigator chooses to use the unapproved article on a second or greater occassion, follow the steps described above. Be advised however that the IRB will have to report this additional use to the FDA. It is possible that the FDA may choose to take action against you if you had the opportunity to obtain IRB approval prior to using the article.